When Cartiva Inc. successfully sped through its Class III device premarket panel in less than half the average time—71 days instead of 159—that caught my attention. For more than 18 years, the Empirical family of companies has partnered with medical device developers to bring new products to market. We know how complicated and time-consuming the Class III approval process can be.

My company was one of several small startups Cartiva Inc. partnered with as the company worked to bring its Cartiva Synthetic Cartilage Implant to market. We performed mechanical testing, but were only one partner in Cartiva’s project. Deborah Moore, Cartiva’s vice president of Clinical, Regulatory, and Quality Affairs, said the firm Hogan Lovells was instrumental in steering her young company’s success with its first product.

“Hogan Lovells was big—they’ve pretty much touched every new product introduction that typically occurs,” Moore said. “They’re at FDA every week. They’ve been involved in more panel meetings than anybody else.”

The consulting firm based in Washington, D.C., serves an international clientele in the medical device space. Randy Prebula, who worked closely with Moore throughout Cartiva’s device development cycle, was a microbiologist with Hogan Lovells before becoming an attorney and partner. The firm has a wide range of experts to help clients navigate the path to market.

“We use a team of legal, scientific, medical, and statistical experts,” he said. “We all work together in the same group. We all listen to what our client is looking for. Then we bring the right team members to achieve that task. Most consulting firms are either regulatory experts or medical experts or legal experts or statistical. We bring all four of those things into play.”

According to Prebula, the right partners for a device development project give you a solid foundation for moving forward.

“[Clients] are not starting from ground zero every time they start a project,” he said. “They’re starting from the 20th floor of a 60-story building, not the basement.”

Regardless of your company size or capabilities, when it comes to outsourcing elements of device development, Prebula said the first issue to understand is basic, but profound.
“You have to have a clear idea about what your technology is and what you want your technology to do,” he said. “FDA will apply the same rules whether you’re a small company or a large company based on those two things. If you don’t have a clear idea of what that is, no amount of outsourcing will help you figure it out.”

As you sift through referrals and recommendations for the most compatible partners, Prebula suggests that in addition to professional accolades, consider the personal dynamics as well.

“You need to look for consultants who are willing to share the floor and play well with others,” he said. “I’m not an expert in everything. If I try to act like I am, I’m doing my client a disservice.”

You also want a vendor who understands and appreciates your budget.

“There are some things we do well; there are other things we know others can do more cost-effectively,” Prebula said. “There’s no point in running up fees and costing clients lots of money if it’s not going to be successful. Let’s find a way together to get you to the goal line without costing you a gold mine.”

Nevertheless, there are certain aspects of the process that are well worth the financial investment.

“Never skimp on communicating early and effectively with FDA,” he said. “If you think you can save a little money by putting something off to the submission instead of having an informal phone call or pre-meeting with FDA, you’re being penny wise and pound foolish.”

And when it comes to regulatory issues, it’s not just a matter of knowing the rules.

“Anybody can tell you what the regulations say,” Prebula said. “It’s different when you explain that in the context of a business. It has to be practical and actionable.”

You also want to work with partners who know how to pick their battles. Prebula said he’s worked with some clients and vendors who push back at every U.S. Food and Drug Administration (FDA) request.

“If the consultant wants to fight FDA on every single data point and question, you’re going to spend more time fighting that than moving forward. That doesn’t mean you don’t challenge things,” Prebula said. “Don’t just reject it out of hand; think about what are they asking and why are they asking it. If there’s a safety question in their mind, you’re going to have to address it.”

Along similar lines, you must also be willing to accept some course corrections as you move forward, Prebula said.

“Let the data and the experts lead you where you’re going to go,” he said. “You always have to follow the facts where they lead. You can’t decide ahead of time what the facts will be. Otherwise, you’re trying to decide an outcome before you know the facts.”

As a consultant, Prebula said he’s sometimes had to tell clients why they may want to abandon the project altogether—something no one wants to hear or explain.

“Being a consultant to a company is sometimes advising them, maybe this is a product you don’t move forward,” he said. “That’s a business decision that I can’t make for my client. But I have to be willing to advise them honestly when that’s an option.”

A solid partner finds the balance between best- and worst-case scenarios so you understand the big picture and options for moving forward.

“If I’m not willing to say ‘probably not,’ I’m doing a disservice to my client,” he said. “They’ve hired me to not only be their advocate but also an adviser. I have to be willing to do both. If you find a consultant who only wants to say yes or only wants to tell you things that can go wrong, you probably want to look for someone who’s a little more balanced.”

Editor’s note: This is the second in a multi-part series on bringing Class III devices to market. Read the first article, “David vs. Goliath: How a Small Startup Managed to Slingshot the FDA Approval Process” in the November/December 2016 issue of ODT.

Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.

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